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Senior Quality Assurance Lead
2 months ago
Quality Assurance Supervisor
This organization is at the forefront of cGMP production and is dedicated to advancing gene therapy. Their mission is to develop innovative, safe, and effective long-term treatments for various conditions by leveraging their expertise, resources, technology, and knowledge in translational and regulatory science. They strive to make a significant impact with each product, instilling hope in patients and their families, regardless of the rarity or complexity of the condition. The core focus of this biotech firm is the comprehensive production of Adeno Associated Viruses (AAV). Annually, they partner with over 100 clients to manufacture AAV across various stages of development, toxicological assessments, and clinical trials.
Qualifications:
- Proficient understanding of team dynamics within the organization
- Thorough knowledge of cGMP, GLP, and FDA regulations
- Exceptional communication, organizational, and project management abilities, with a proven capacity to handle multiple projects and adapt to shifting priorities
- Advanced skills in Microsoft Office Suite (PowerPoint, Excel, Word), including data analysis and reporting
- Ability to work autonomously as well as collaboratively in a diverse and inclusive environment
- Client-focused approach in daily responsibilities
Responsibilities:
- The QA Operations Supervisor is tasked with supporting internal Quality Assurance activities centered on GMP manufacturing processes and related Quality systems, including change controls and internal process verification.
- This role involves collaborating with the training team to ensure compliance with Quality systems among manufacturing personnel.
- Implement Quality systems to facilitate CDMO manufacturing and lot release, GxP auditing, and training initiatives.
- Provide quality assurance support for both external and internal AAV and Plasmid manufacturing as well as clinical product distribution.
- Review and audit complex documentation such as batch records, GMP protocols, and process validations.
- Support the Product Disposition of client AAV and Plasmid lots for release.
- Review and authorize master and executed batch records.
- Observe manufacturing operations to promote the adoption of best practices and enhancements.
- Administer, review, and approve internal/external Deviations, Change Records, and Corrective and Preventive Actions (CAPAs).
- Manage the Document Management System by authoring, reviewing, and approving Policies, SOPs, and Work Instructions as necessary.
- Communicate quality metrics, client production tracking, and quality improvement initiatives to senior management.
- Provide oversight and contribute to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.
- Act as a Quality Assurance Subject Matter Expert during client and regulatory audits.
- Schedule QA-on-the-floor responsibilities for the QA Operations team to support manufacturing activities.
- Ensure that documentation is maintained in accordance with internal protocols and regulatory standards.
- Foster an environment that encourages communication and teamwork within Quality Assurance and related departments.
- Exercise discretion, judgment, and personal accountability.
Benefits:
- Opportunity to collaborate with experts with over a decade of experience in the gene therapy sector.
- Competitive salary package.
- Immediate eligibility for medical, dental, and vision insurance plans, with basic vision fully covered by the company.
- 160 hours of Paid Time Off each year.
- 11 Company Paid Holidays plus 2 floating holidays annually.
- Company Paid Life Insurance.
- 401(k) Matching program.
- Company Paid short and long-term disability coverage.
- 4 weeks of Paid Parental Leave for birth and adoption.
- Adoption Assistance programs.
- Tuition Reimbursement and Student Loan Repayment Assistance.
- Access to Company Paid LinkedIn Learning resources.
- Employee Assistance Programs available.
- Flexible work arrangements (role-specific).
